Senior GMP Specialist

3 weeks ago

Lyngby, Denmark COWI Full time

Senior GMP specialists and consultants for pharmaceutical manufacturing facility projects - Denmark

Do you want to play a key role in building a strong internal environment with the capacity, knowledge and services needed to execute projects and provide advisory services to our customers within the life sciences and pharmaceutical sectors? Do you have an excellent understanding of, and experience with GMP requirements for pharmaceutical facilities? And can you offer support throughout all project phases, from scoping and design to completion and handover? Then, join our GMP team to apply your knowledge and enable a better tomorrow

Shaping tomorrow - transform challenges into sustainable solutions.

 part of COWI's Building and Industry Division in Denmark, you will join a growing group of GMP specialists in our pharma team. The team consists of project managers, design managers and specialists and we have several hundred colleagues working in the pharmaceutical market. Our ambition is to establish an even stronger presence in this market.

The position.

Your main responsibilities will be divided into two areas.

Internally: As part of our GMP team, you will strengthen our competencies in executing pharmaceutical projects. This includes taking ownership of developing qualification and validation concepts for new builds, refurbishments, reconstructions and development projects within the GMP team. You will also educate and guide project members, prepare internal procedures etc. Externally: You will manage the full scope of GMP requirements in our specific pharmaceutical projects, to position us as a valued and preferred partner in the market and broaden our scope holistically. You will be an integral part of project teams across our departments, taking responsibility for activities such as CQV on clean rooms, temperature-regulated rooms, utilities and other areas subjected to GMP regulations. You will also serve as a sparring partner for project teams and work closely with customers to understand their requirements and expectations.

Your skills. Our team. Together we design the future.

To succeed in this role, you should have a strong desire to be part of the execution of COWI's pharma strategy and the continuous development of the pharma team, along with curiosity and a willingness to collaborate with colleagues, partners, and customers. Building meaningful connections with others is achieved through respectful interactions and consistently delivering on your commitments. Additionally, you should remain open to exploring new insights and methods of improvement.

In addition to the skills mentioned above, the ideal candidate will have:

An excellent understanding of GMP requirements and risk-based approach for pharmaceutical production (API and finished products). Experience in developing strategies for the qualification and validation of equipment and facilities, along with preparing requirement specifications to ensure quality assurance throughout all project stages. This includes expertise in documentation for risk assessment, commissioning, qualification, validation, and execution. Knowledge of design requirements for clean rooms and containment-controlled facilities, including biosafety and GMO. A relevant academic background, with a bachelor’s or master’s degree in engineering, biology, chemistry or pharmacy. A minimum of 5-10 years of work experience in the bio- and pharmaceutical industry, both in Denmark and abroad. Strong communication skills in English, both written and verbally, and preferably as well in Danish. A mindset focused on quality and a systematic approach to preparing documentation and verifying equipment and facilities subjected to GMP regulations. Willingness to contribute and provide guidance to highly skilled colleagues regarding GMP matters and facility design for pharmaceutical customers. Experience in a QA or pharmaceutical production department could be beneficial, as well as experience in conducting internal training and knowledge of clean room/containment-controlled environments.

A Great Place to Work

At COWI, we work together with our customers to shape a sustainable and liveable world. We do it by applying our knowledge and curiosity – and sometimes even our courage – to create the solutions the world needs today to enable a better tomorrow. That is why we say no to fossil-based projects and aspire to have % of our revenue come from activities that move our customers towards sustainability.

We value differences and development and cultivate an environment of belonging and having fun. Because that is what brings out the best in you, at work and at home.

With offices primarily located in the Nordic region, the UK, North America and India, we are currently more than 8, people who bring their expertise in engineering, architecture, energy and environment into play.

Got More Questions?

If you have any unanswered questions about the role or what we have to offer, please reach out to our Leading Project Manager, Arne Winther Nielsen, via email: .

Get to know us even better at our website, where you can learn more about our projects, our strategy, what we want to achieve and what life is like at COWI.

We do our utmost to ensure that our recruitment process is as fair and unbiased as possible. You can help us by not including a photo in your CV when you apply.

Diversity is fundamental to COWI, inclusion is key.

We are committed to creating a respectful and fair work environment where all employees have a sense of belonging and equitable opportunities to thrive and grow. We ensure that our leaders are role models for inclusive leadership by cultivating a culture where diverse perspectives and thoughts are seen as strengths. And we take diversity and inclusion into account in all relevant decisions and processes and when setting teams and fora. We do it because it is part of our values and because it is simply the right thing to do.

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